Background:
Crataegus preparations have been used for centuries especially in Europe. To date, no proper data on their efficacy and safety as an add‐on‐treatment are available. Therefore a large morbidity/mortality trial was performed.
Aim:
To investigate the efficacy and safety of an add‐on treatment with Crataegus extract WS® 1442 in patients with congestive heart failure.
Methods:
In this randomised, double‐blind, placebo‐controlled multicenter study, adults with NYHA class II or III CHF and reduced left ventricular ejection fraction (LVEF≤35%) were included and received 900 mg/day WS® 1442 or placebo for 24 months. Primary endpoint was time until first cardiac event.
Results:
2681 patients (WS® 1442: 1338; placebo: 1343) were randomised. Average time to first cardiac event was 620 days for WS® 1442 and 606 days for placebo (event rates: 27.9% and 28.9%, hazard ratio (HR): 0.95, 95% CI [0.82;1.10]; p=0.476). The trend for cardiac mortality reduction with WS® 1442 (9.7% at month 24; HR: 0.89 [0.73;1.09]) was not statistically significant (p=0.269). In the subgroup with LVEF ≥ 25%, WS® 1442 reduced sudden cardiac death by 39.7% (HR 0.59 [0.37;0.94] at month 24; p=0.025). Adverse events were comparable in both groups.
Conclusions:
In this study, WS® 1442 had no significant effect on the primary endpoint. WS® 1442 was safe to use in patients receiving optimal medication for heart failure. In addition, the data may indicate that WS® 1442 can potentially reduce the incidence of sudden cardiac death, at least in patients with less compromised left ventricular function.